Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Computed Tomography Angiography, High Risk Cardiovascular Disease Population, Prevention, Atherosclerosis
Brief summary
The CARDIAC trial is a prospective, parallel, open-label cluster randomized trial that aims to determine the effectiveness of a coronary computed tomography angiography (CTA)-guided intensive intervention strategy, as compared with standard care, on reducing the incidence of major adverse events (MACE) at 18 months among high-risk cardiovascular populations in rural China. An extended observational follow-up at 36 months will be conducted to further evaluate the effect on long-term clinical outcomes.
Detailed description
The CARDIAC trial aims to determine the effectiveness of a coronary CTA-guided intensive intervention strategy, as compared with standard care, on improving clinical outcomes among population at high risk for cardiovascular disease in rural China. This cluster randomized trial will be conducted in 428 rural villages in China. The study will recruit 35 individuals at high risk for cardiovascular disease from each village for a total of 14,980 participants. The participating villages will be randomly assigned to experimental group (CTA-guided group) and control group (standard care group) with 1:1 allocation. Study participants will be followed at 1, 3, 6, 12, and 18 months. The primary outcome is major adverse cardiovascular events (MACE, a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke) at 18 months. In addition, an extended observational follow-up will be conducted at 36 months, to evaluate long-term outcomes (i.e., MACE).
Interventions
DIAGNOSTIC_TESTCTA-guided Intensive Intervention Strategy
Intensive intervention strategies based on the result of coronary computed tomography angiography
OTHERComprehensive Intervention Strategy
Comprehensive intervention strategies based on guidelines and expert consensus
Sponsors
Harbin Medical University
Daqing Oil Field Hospital
Heilongjiang Provicial Hospital
The First Hospital Of Qiqihar
Mudanjiang Cardiovascular Hospital, China
Hongqi Hospital Affiliated to Mudanjiang Medical University
The Third Affiliated Hospital of Qiqihar Medical University
The Baoquanling Hospital of Beidahuang Group
Daqing Longnan Hospital
The First Hospital of Suihua City
Jiamusi Central Hospital
Beidahuang Industry Group General Hospital
The First Affiliated Hospital of Jiamusi University, China
Shuangyashan Shuangkuang Hospital
Beijing Peking University WBL Biotech Co., Ltd.
Hegang People Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open-label, assessor-blinded
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria of study villages: 1. Administrative villages 2. The village has no plans to merge with other villages within 3 years 3. The village is at least 2 kilometers away from other participating villages 4. The village has a sufficient number of study participants 5. The village is able to cooperate with the implementation of the study Inclusion criteria of study participants: 1. Men or women aged between 40 and 75 years 2. Live stably in the province where the study is conducted and no intention to migrate within next 3 years 3. Not participating in other clinical trials 4. Meet any of the following: (1)Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 4.9 mmol/L or Total Cholesterol (TC) ≥ 7.2 mmol/L (2)Diabetes mellitus (3)Chronic Kidney Disease (CKD) Stage 3-4: estimated Glomerular Filtration Rate (eGFR) 15-59 mL/min/1.73m\^2 (4)With a history of hypertension and 3 risk factors, combined with LDL-C ≥ 1.8 mmol/L or TC ≥ 3.1 mmol/L \[Risk factors (assessed pre-intervention): smoking, low HDL-C, male ≥ 45 years old or female ≥ 55 years old\] (5)With a history of hypertension and 2 risk factors, combined with LDL-C ≥ 2.6 mmol/L or TC ≥ 4.1 mmol/L \[Risk factors (assessed pre-intervention): smoking, low HDL-C, male ≥ 45 years old or female ≥ 55 years old\] 5. Sign the informed consent
Exclusion criteria
1. Unwillingness or inability to undergo coronary CTA examination (e.g., previous history of severe contrast allergy, claustrophobia, or inability to cooperate with scanning and breath-holding for physical reasons in study participants) 2. Typical angina symptoms, known coronary artery disease, or other major atherosclerotic cardiovascular disease 3. Known cerebrovascular disease (e.g., cerebral hemorrhage, cerebral infarction, etc. ) 4. Prior invasive or non-invasive coronary angiography within the last 5 years 5. Known familial hypercholesterolemia or other inherited disorders of lipid metabolism requiring lipid-lowering therapy 6. Presence of active bleeding or diseases with a very high risk of bleeding (e.g., active peptic ulcer disease, gastrointestinal pathologies with increased risk of bleeding, hematologic disorders with increased risk of bleeding, etc.) 7. End-stage diseases such as cirrhosis decompensation, with life expectancy \<3 years 8. Have a malignant tumor 9. Intolerance of all statins 10. Lipid-lowering treatment for \>2 years 11. Pregnant or breastfeeding, planning to become pregnant within the next 3 years 12. eGFR \<30 mL/min/1.73m\^2 13. Platelet count \<100×10\^9/L 14. Poor compliance, unable to cooperate with study investigators 15. Investigators consider unsuitable for participants selected for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 18 months | Time to first occurrence of any of the following: all-cause death, non-fatal myocardial infarction, or non-fatal stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause death | 18 months | Number of cardiovascular and non-cardiovascular death |
| Myocardial infarction | 18 months | Number of fatal and non-fatal myocardial infarction |
| Stroke | 18 months | Number of fatal and non-fatal stroke |
| Hospitalization for chest pain | 18 months | Number of hospitalization due to cardiac chest pain and hospitalization due to non-cardiac chest pain |
| Coronary revascularization | 18 months | Number of percutaneous coronary intervention and coronary artery bypass grafting procedures |
| Invasive coronary angiography | 18 months | Number of invasive coronary angiography |
| The proportion of antiplatelet drugs and lipid-lowering drugs used | Baseline and 1 month, 3 months, 6 months, 12 months, 18 months | The proportion of antiplatelet drugs and lipid-lowering drugs used |
| Changes in lipid levels | Baseline and 18 months | Changes in TC, LDL-C, HDL-C, and TG |
| Change in quality of life (EQ-5D-5L) | Baseline and 18 months | Change in quality of life measured using EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire: The first part is a descriptive system, assessing health in five dimensions. Each dimension has 5 levels from no problems to extreme problems (0-5), with higher scores for lower quality of life. The second part consists of a Visual Analogue Scale (VAS), assessing the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life. |
| MACE at 36 months | 36 months | Time to first occurrence of any of the following: all-cause death, non-fatal myocardial infarction, or non-fatal stroke |
Countries
China
Outcome results
None listed